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临床试验/NCT01057329
NCT01057329已完成不适用

Therapeutic Drug Monitoring (TDM) in Child & Adolescent Psychiatry

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2010年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Blood level concentrations of the drugs in use;

研究概览

简要总结

The investigators aim to analyse in adolescents with mental illness effectiveness, side effects, and serum level concentrations of antipsychotics (olanzapine and aripiprazole), antidepressants (Duloxetine, Atomoxetine) by means of "Therapeutic Drug Monitoring" (TDM) in order to optimize dosage - effect relations and minimize unwanted side effects.

详细描述

We aim to analyse in adolescents with mental illness effectiveness, side effects, and serum level concentrations of antipsychotics (olanzapine and aripiprazole), antidepressants (Duloxetine, Atomoxetine) by means of "Therapeutic Drug Monitoring" (TDM) in order to optimize dosage - effect relations and minimize unwanted side effects.

Therapeutic drug monitoring is becoming a quality measure in psychopharmacotherapy in adults and children and has been used successfully recently (Hiemke 2008). In 2007, the German Child & Adolescent Psychiatry University Clinics have founded a network the "TDM-network" headed by Profs. C. Mehler-Wex and J. Fegert in Ulm (www.tdm-kjp-de). The Viennese Child and Adolescent Clinic is part of this network. Most importantly, this network must and wants to be independent from the pharmaceutical industry in order to get un-biased scientific results and data. Within this network, which has been successfully established in the participating clinical departments it is possible to take the lead in several scientific areas.

Highest ethical standards, data-protection and rigorous designs are needed to protect childrens' and adolescents' rights.

Therapeutic drug monitoring (TDM) and its implication for treatment and research: By definition, TDM signifies the dosage of a drug by controlling its concentration in serum. It aims at establishing the therapeutical range of the drug given and thus at minimizing the risk of over- or undermedication (Pschyrembel 2002). Indications for therapeutic drug monitoring in general comprise the following aspects: - Poor response to the administered drug despite a clinically established dosage - Severe side effects despite a clinically established dosage - Combining medications which bear potential to interact adversely with each other - Treatment of patients at risk (immunosuppression, patients in intensive care, patients at need of longterm treatment, patients with a high level of comorbidity or genetic abberations, patients at risk of non-compliance)- Questionable adherence to the treatment regime -Child and adolescent populations

The scientific background of TDM refers to the assumption that the serum concentration of substances along with their active metabolites represent a better measure of their concentration in the brain as the actual dose (Laux & Riederer, 1992; Baumann et al., 2004). Additionally, it is stated that there is a defined relation between serum concentration and clinical effect. This correlation could be confirmed e.g. for the tricyclic antidepressants imipramine und desipramine (Baumann et al., 2004).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
10 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • appropriate diagnosis and severity of the disorder of interest
  • age range 10-19

排除标准

  • below 10 yrs of age
  • no written informed consent possible due to intelligence or no willingness by parents to include minor

研究组 & 干预措施

Anorexia nervosa

36 severe AN patients treated with aripiprazole

干预措施: Aripiprazole (Drug)

Anorexia

36 severe anorexia nervosa patients treated with olanzapine

干预措施: Olanzapine (Drug)

Anorexia

36 severe anorexia nervosa patients treated with olanzapine

干预措施: Aripiprazole (Drug)

Attention Deficit Hyperactivity Disorder

30 ADHD patients treated with atomoxetine

干预措施: Atomoxetine (Drug)

Depressive disorder

30 depressed patients treated with duloxetine

干预措施: Duloxetine (Drug)

结局指标

主要结局

Blood level concentrations of the drugs in use;

时间窗: 5 weeks

Blood level concentration of the druns in use

次要结局

  • Level of symtomatology(5 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Andreas Karwautz

Univ. Prof. Dr.

Medical University of Vienna

研究点 (1)

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